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Xarelto Becomes the First DOAC FDA-Approved for Use in Pediatric Patients After Fontan Procedure
Xarelto Becomes the First DOAC FDA-Approved for Use in Pediatric Patients After Fontan Procedure
Xarelto Becomes the First DOAC FDA-Approved for Use in Pediatric Patients After Fontan Procedure
January 20, 2022
The Janssen drug is the only DOAC available in an oral suspension, which facilitates pediatric weight-based dosing.
US Drug Prices, Healthcare Spending Soars
US Drug Prices, Healthcare Spending Soars
US Drug Prices, Healthcare Spending Soars
January 19, 2022
United States healthcare spending rose 9.7% in 2020, while medication spending is increasing by more than 18%.
FDA Clears Two JAK 1 Inhibitors for Atopic Dermatitis
FDA Clears Two JAK 1 Inhibitors for Atopic Dermatitis
FDA Clears Two JAK 1 Inhibitors for Atopic Dermatitis
January 17, 2022
The FDA okayed two Janus kinase 1 (JAK1) JAK inhibitors January 14 the for atopic dermatitis: Cibinqo and Rinvoq.
Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm
Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm
Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm
January 15, 2022
In a research letter published in JAMA Health Forum, researchers say most of the cost figures for Aduhelm have left out the additional MRI scans and other services that will be required because the drug is associated with the development of amyloid-related imaging abnormalities (ARIAs).
In First 2022 Recall, Metformin Pulled Back Because of Carcinogenic NDMA
In First 2022 Recall, Metformin Pulled Back Because of Carcinogenic NDMA
In First 2022 Recall, Metformin Pulled Back Because of Carcinogenic NDMA
January 14, 2022
Problems with N-nitrosodimethylamine (NDMA)-contaminated metformin were identified by the FDA in 2020. Viona Pharmaceuticals announced in earlier this month that it was recalling 23 lots of the popular diabetes medication.
Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.
Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.
Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.
January 13, 2022
Leo Pharma's Adbry (tralokinumab-ldrm) is the second, FDA-approved biologic for atopic dermatitis. Dupixent (dupilumab) was the first.
Analyst: CMS Decision Will “Significantly Limit" Biogen’s Aduhelm
Analyst: CMS Decision Will “Significantly Limit" Biogen’s Aduhelm
Analyst: CMS Decision Will “Significantly Limit" Biogen’s Aduhelm
January 13, 2022
CMS has proposed covering the anti-amyloid treatment only if the person taking it is enrolled in a clinical trial.
Analyst Report: These 7 Treatments Destined To Be Blockbusters Within 5 Years
Analyst Report: These 7 Treatments Destined To Be Blockbusters Within 5 Years
Analyst Report: These 7 Treatments Destined To Be Blockbusters Within 5 Years
January 10, 2022
Lecanemab and donanemab, monoclonal antibodies for Alzheimer’s, are on the list of drugs in late-stage development that Clarivate analysts will have annual sales of a $1 billion or more in the next five years.
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
January 6, 2022
Leqvio (inclisiran) is the first small interfering RNA therapy approved to lower LDL cholesterol in certain adults at risk for life-threatening cardiovascular events.
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
January 5, 2022
But Paxlovid and molnupiravir will be available only at certain Walmart and Sam’s Club locations.
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
January 3, 2022
A review of real-world data from Israel didn't show any increase risk of myocardities or pericarditis.
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's  in 2022
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's  in 2022
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's in 2022
January 2, 2022
ICER's analysis is slated to include two as-yet unapproved monoclonal antibody treatments, donanemab and lecanemab, as well as Aduhelm (aducanumab).
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
December 31, 2021
The FDA has approved Amgen and AstraZeneca’s Tezspire (tezepelumab-akko) for severe asthma. But the drug may have limited uptake in the near term, according to one analyst.
Best Read Articles on Safety Issues and Recalls in 2021
Best Read Articles on Safety Issues and Recalls in 2021
Best Read Articles on Safety Issues and Recalls in 2021
December 30, 2021
News about counterfeit versions of Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) and Descovy (emtricitabine, tenofovir alafemamide) and the pause in the REMS program for clozapine were among the best read articles of 2021.
Best Read Articles on Formularies and Formulary Changes in 2021
Best Read Articles on Formularies and Formulary Changes in 2021
Best Read Articles on Formularies and Formulary Changes in 2021
December 29, 2021
Our best read stories about formularies include news about 2022 formularies from CVS Caremark and Express Scripts.
Best Read Articles on Biosimilars in 2021
Best Read Articles on Biosimilars in 2021
Best Read Articles on Biosimilars in 2021
December 28, 2021
News about interchangeable Semglee (insulin glargine-yfgn) was among the most read in 2021.
Best Read Articles on News Not Related to COVID-19 in 2021
Best Read Articles on News Not Related to COVID-19 in 2021
Best Read Articles on News Not Related to COVID-19 in 2021
December 27, 2021
Apotex's importation of Chantix (varenicline) and Express Scripts' formulary exclusions were among the best read articles this year that didn't concern COVID-19.
Best Read Articles on FDA News in 2021
Best Read Articles on FDA News in 2021
December 26, 2021
The FDA's warning about Xeljanz (tofacitinib) and other JAK inhiitors and the extension of its review of Janssen's CAR T therapy for multiple myeloma were among the best read articles about the agency in 2021.
Best Read Articles on COVID-19 Drug-Related News in 2021
Best Read Articles on COVID-19 Drug-Related News in 2021
Best Read Articles on COVID-19 Drug-Related News in 2021
December 25, 2021
The attention-getting articles about COVID-19 included news about Pfizer's booster and the FDA's rejection Zyesami (aviptadil) for treatment of COVID-19-related respiratory failure.
Best Read Articles on FDA Approvals in 2021
Best Read Articles on FDA Approvals in 2021
Best Read Articles on FDA Approvals in 2021
December 24, 2021
The approval of the generic version of smoking-cessation drug Chantix (varenicline) garnered a lot of attention as did the OKs of Besremi (ropeginterferon alfa-2b-njft), a treatment for polycythemia vera, and Trudhesa (dihydroergotamine mesylate), a nasal spray for acute treatment of migraines.
Quality of Patient-Reported Outcomes in Oncology Trials Improves
Quality of Patient-Reported Outcomes in Oncology Trials Improves
Quality of Patient-Reported Outcomes in Oncology Trials Improves
December 23, 2021
Reporting of PRO in oncology clinical trials increased after standards from ISOQOL and others were published in 2013.
Areva to Import Bupivacaine from Italy
Areva to Import Bupivacaine from Italy
Areva to Import Bupivacaine from Italy
December 22, 2021
This is the Areva's second importation of bupivacaine this year.
Monoclonal Antibody for Relapsing MS on the Way
Monoclonal Antibody for Relapsing MS on the Way
Monoclonal Antibody for Relapsing MS on the Way
December 21, 2021
The FDA has set a Prescription Drug User Fee Act goal date of Sept. 28, 2022.
Study: Increasing Medicaid Rebates on Accelerated Approvals Saves Money
Study: Increasing Medicaid Rebates on Accelerated Approvals Saves Money
Study: Increasing Medicaid Rebates on Accelerated Approvals Saves Money
December 20, 2021
During the period 2015 to 2020, if a proposed policy that increases Medicaid rebates for drugs with accelerated approvals had been enacted, up to $5.2 billion could have been saved.
FDA Updates REMS for CAR T-Cell Therapies
FDA Updates REMS for CAR T-Cell Therapies
FDA Updates REMS for CAR T-Cell Therapies
December 17, 2021
Because of a COVID-19 related shortage, facilities may not have immediate access to Actemra, which is required as part of the REMS programs for CAR T-cell therapies.
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